Amitiza (lubiprostone) / Takeda, Mallinckrodt - LARVOL DELTA

STOPS 03: Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation (clinicaltrials.gov) - P3 | N=346 | Recruiting | Sponsor: Third Military Medical University

New P3 trial • Constipation • Gastroenterology • Gastrointestinal Disorder

Effect of Multiple Pharmacological Interventions and Magnetic Control on Capsule Endoscopy Gastrointestinal Transit Time and Diagnostic Yield: A Systematic Review and Meta-Analysis. (PubMed, JGH Open) - "Erythromycin and magnetic guidance were consistently associated with faster gastric passage, while lubiprostone and polyethylene glycol (PEG) shortened SBTT compared with control groups. For improving overall completion, metoclopramide remains a dependable option. These findings support individualized preparation strategies tailored to the specific diagnostic goals of CE."

Journal • Retrospective data

Bali Chronic Constipation Roundtable Report: Chronic Constipation Management in Asia. (PubMed, J Neurogastroenterol Motil) - "First line therapies such as dietary-fiber optimization and osmotic laxatives are widely available, but newer pharmacotherapies (prucalopride, linaclotide, lubiprostone, and elobixibat) remain costly and unevenly accessible. The Bali Chronic Constipation Roundtable highlighted Asia's need for region specific diagnostics and management. Addressing diagnostic and treatment gaps will improve outcomes, while ongoing researcher clinician policy collaboration must standardize guidelines, advance research, and ensure equitable care across Asia."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Bioelectric Reprogramming of the Bone Marrow Niche in Acute Myeloid Leukemia (ASH 2023) - "On the contrary, we treated AML-MSCs with hyperpolarizing agents (lubiprostone and ivermectin), which reverted their phenotype to that of h-MSCs, including lower proliferation level (ivermectin -1.9-fold, p<0.05), higher immunomodulatory potential, and higher CaV1.2 levels (1.8-fold by flow cytometry, p<0.05) with respect to untreated AML-MSCs, suggesting that depolarization is reversible and that by modeling MSCs Vmem we can restore an healthy stroma within the BM niche...In addition, we unveiled CaV1.2 channels as a key player in this process and postulated that rewriting the bioelectric code of the patient' AML-MSCs, through the restoration of voltage-dependent calcium channel CaV1.2 activity, could be a strategy to restore their healthy phenotype. These findings provide the biological rationale to evaluate the potential of novel MSCs gene or pharmacological therapies that could both disadvantage AML progression and restore a permissive BM niche."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • IL6

Lubiprostone in CKD: Insights into Mitochondrial Function and Polyamines from a Randomized Phase 2 Clinical Trial (KIDNEY WEEK 2025) - "Key findings of this work are under revision for publication. Clinical Trials Registry Number: UMIN000023850"

Clinical • P2 data • Chronic Kidney Disease • Constipation • Gastroenterology • Gastrointestinal Disorder • Nephrology • Renal Disease

Regulation and mechanism of chloride channels in proliferative vitreoretinopathy. (PubMed, Medicine (Baltimore)) - "By reducing the opening of chloride channels within RPE cells via drugs, PVR formation can be suppressed, which is sufficient to counteract retinal degeneration. Chloride channels may have crucial effects on RPE cell proliferation and migration. The therapeutic strategy of blocking chloride channels may be beneficial for PVR."

Journal • Ophthalmology • Retinal Disorders • TGFB1

Efficacy of Lubiprostone in Preventing Constipation After Total Knee Arthroplasty: A Multicenter, Prospective, Randomized Controlled Trial (ChiCTR) - P4 | N=212 | Not yet recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

New P4 trial • Constipation • Gastroenterology • Gastrointestinal Disorder • Orthopedics • Pain

Combined Efficacy of Methylnaltrexone and Naloxegol in Managing a Case of Neurogenic and Opioid-Induced Constipation (ACG 2025) - "His bowel regimen is polyethylene glycol 17g 3 times a day, lubiprostone 24mcg daily, 2 tablet of senna 8.6mg twice daily, and naloxegol 12.5mg daily. (2020), which show methylnaltrexone's efficacy in opioid-treated patients. While promising, further research is needed to assess the long-term safety and efficacy of this combined approach in similar patient populations."

Clinical • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Multiple Sclerosis

Real-World Safety Analysis of the Constipation-Predominant Irritable Bowel Syndrome Treatment Options Linaclotide, Lubiprostone, Plecanatide, and Tenapanor (ACG 2025) - "Linaclotide was suspected of frequently inducing diarrhea (n=2,082, 24.1%), abdominal pain (n=815, 9.4%), abdominal bloating (n=795, 9.2%), and nausea/vomiting (n=266, 3.1%). Plecanatide was suspected of frequently inducing diarrhea (n=137, 20.4%), abdominal pain (n=76, 11.3%), abdominal bloating (n=62, 9.2%), and nausea/vomiting (n=34, 5.1%). Tenapanor was suspected of frequently inducing diarrhea (n=51, 32.9%), abdominal pain (n=13, 8.4%), and abdominal bloating and nausea/vomiting (n=11 each, 7.1%)."

Clinical • Real-world • Real-world evidence • Constipation • Gastroenterology • Gastrointestinal Disorder • Pulmonary Disease

Rectal Bleeding as the Initial Presentation of Prostate Adenocarcinoma With Direct Rectal Invasion: A Case Report (ACG 2025) - "Current treatment includes both radiation therapy and hormonal therapy with lubiprostone. This case highlights the need to consider prostate cancer with rectal invasion as a potential cause in elderly male patients presenting with rectal bleeding and rectal masses that appear atypical for primary colorectal...A multidisciplinary approach is essential for effective management.Figure: Prostate mass directly invading the rectumFigure: A. Hematoxylin and Eosin, 400XB. Prostate specific antigen immunization (Ventana, Roche, Tucson, Arizona), 400X"

Case report • Clinical • Colorectal Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • ACPP • CDX2 • PSAP

Outpatient Management of Partial Small Bowel Obstruction Using an Oral Palatable Elemental Diet (ACG 2025) - "Given her prior postoperative complications, she has been understandably hesitant to undergo surgical lysis of adhesions.Episodes of pSBO would occur despite multiple gut-directed treatments including lubiprostone, linaclotide, plecanatide, pyridostigmine, and rifaximin daily. Elemental diets provide complete nutrition with high absorptive efficiency in the proximal small bowel. Being fiber- and residue-free, they present an intriguing option for the conservative management of partial bowel obstruction.Figure: Figure 1) Serial abdominal radiographs demonstrating the progression and resolution of partial small bowel obstruction in response to outpatient exclusive elemental diet consumption in 2024.Figure: Figure 2) Serial abdominal radiographs demonstrating the progression and resolution of partial small bowel obstruction in response to outpatient elemental diet consumption in 2025."

Clinical

Chronic Constipation and Small Bowel Obstruction as a Complication of Uterine Fibroids (ACG 2025) - "Trials of lubiprostone and linaclotide did not provide relief. UAE was successfully performed, leading to symptomatic relief and resolution of the obstruction without the need for surgical resection. This case underscores the importance of considering pelvic pathology in the differential diagnosis of bowel obstruction and chronic constipation in women and demonstrates the utility of UAE as a minimally invasive, fertility-sparing therapeutic option in select patients.Figure: Uterine Fibroids Causing Sigmoid NarrowingFigure: CT Coronal View Uterine Fibroids"

Constipation • Gastroenterology • Gastrointestinal Disorder • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

New Kid on the Block: Could Suzetrigine's Promise of Pain Relief Improve Outcomes in Management of DGBI? (ACG 2025) - "He tried linaclotide, plecanatide, lubiprostone, prucalopride, and tenapanor...Adjunct pharmacological neuromodulators like nortriptyline, duloxetine and gabapentin were not helpful...She responded partially to duloxetine, buspirone, mirtazapine, and cognitive behavioral therapy...Studies have directly and indirectly established the importance of NaV1.8 to visceral pain perception (Table 1). Additional trials are needed to evaluate the impact of this medicine on visceral pain perception especially in conditions associated with acute and/or chronic abdominal pain, including DGBIs.Figure: Summary of Studies Supporting the Role of Nav1.8 in Visceral Pain Perception"

Cardiovascular • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Mood Disorders • Novel Coronavirus Disease • Pain • Psychiatry • NAV1

Cost-utility analysis of treatment strategies for chronic constipation in Japan. (PubMed, J Gastroenterol) - "The lubiprostone-elobixibat-PEG formulation strategy showed the most favorable cost-effectiveness profile. In addition, novel treatment options, including lubiprostone, linaclotide, elobixibat, and PEG formulation, were found to be cost-effective compared to MgO. Further research is warranted to confirm these findings and support their application in clinical practice."

HEOR • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

GUILLAIN-BARRÉ SYNDROME SECONDARY TO WEST NILE VIRUS IN WEST VIRGINIA (CHEST 2025) - "Additionally, he received antibiotics for Haemophilus influenza pneumonia and was diagnosed with Ogilvie syndrome, which improved with bowel regimen and Lubiprostone... This case emphasizes the need for healthcare providers to remain vigilant for WNV in patients presenting with GBS symptoms, even in regions where its prevalence is low."

Cough • Immunology • Infectious Disease • Influenza • Otorhinolaryngology • Pneumonia • Respiratory Diseases • Sinusitis

Socioeconomic value of treatments for chronic idiopathic constipation in Japan. (PubMed, BMC Gastroenterol) - "Considering CIC-related medical costs, QoL, productivity loss, and caregiver burden, elobixibat 10 mg is associated with better QoL and lower costs than linaclotide 0.5 mg and lubiprostone 48 μg."

Clinical • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Efficacy and safety of pharmacological therapies for functional constipation in children: a systematic review and meta-analysis. (PubMed, Lancet Child Adolesc Health) - "Polyethylene glycol is probably more effective than placebo and key comparator therapies and should be considered the standard of first-line care. Future studies should consider polyethylene glycol as an index therapy, and clearly describe methods, patient characteristics, and previous therapeutics."

Journal • Retrospective data • Constipation • Gastroenterology • Gastrointestinal Disorder

Efficacy and safety of lubiprostone combined with polyethylene glycol electrolyte powder for bowel preparation in patients classified by risk level: a randomised trial. (PubMed, Front Oncol) - P4 | "However, in patients classified as low-risk, the addition of lubiprostone does not provides additional benefits. https://clinicaltrials.gov, identifier ChiCTR2400088155."

Journal • Anesthesia • Cardiovascular • CNS Disorders • Colorectal Cancer • Constipation • Diabetes • Gastroenterology • Gastrointestinal Disorder • Metabolic Disorders • Movement Disorders • Orthopedics • Parkinson's Disease

Association between use of lubiprostone and headache: A systematic review and meta-analysis of randomized controlled trials. (PubMed, Br J Clin Pharmacol) - "The results of this meta-analysis suggest that lubiprostone treatment increases the risk of headache in adults."

Journal • Retrospective data • Review • Pain

Laxative logic: when lifestyle is not enough. (PubMed, Curr Opin Gastroenterol) - "Patients with constipation now have access to a wide range of medications, from over-the-counter osmotic and stimulant agents to prescription laxative combination strategies. This breadth allows clinicians to tailor therapy to diverse pathophysiology and symptom profiles. Yet despite this choice, real-world adherence remains poor and many patients are dissatisfied, reflecting the complexity of treating constipation and frequent mismatches between therapy and patients' most bothersome symptoms. Management should emphasize careful symptom assessment, shared decision-making, and clear expectation setting, while leveraging the available armamentarium."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Lubiprostone in chronic kidney disease: Insights into mitochondrial function and polyamines from a randomized phase 2 clinical trial. (PubMed, Sci Adv) - "Multiomics analysis revealed that lubiprostone modulated the gut microbial agmatine pathway and increased spermidine levels, thereby improving renal mitochondrial function. Lubiprostone is a previously unknown and safe therapeutic option to mitigate renal decline in CKD."

Clinical • Journal • P2 data • Chronic Kidney Disease • Constipation • Gastroenterology • Gastrointestinal Disorder • Nephrology • Renal Disease

Effect of magnetically guided capsule endoscopy on gastrointestinal transit time and diagnostic yield: a systematic review and meta-analysis. (PubMed, BMC Gastroenterol) - "No single intervention optimizes all CE parameters. Erythromycin and magnetic control are effective for rapid gastric transit, while lubiprostone and PEG expedite small bowel transit. To maximize the likelihood of a complete examination, metoclopramide is a well-supported option. These findings allow clinicians to select a tailored pre-procedural strategy based on the specific goals of the CE examination."

Journal • Retrospective data

Regulatory effects of 2'-FL combined with Lactobacillus plantarum on the microbiome-gut-brain axis in constipation-type depression (ACS-Fall 2025) - "Currently,Veruquestra, Lubiprostone, and Linaclotide are commonly used to alleviate constipation, but prolonged use may cause dependence, resistance, and significant side effects...By assessing intestinal transit rate, time to first black stool, various behavioral tests, serum inflammatory factors, brain neurotransmitter levels, gut microbiota composition, and related protein expression in loperamide-induced constipated and depressed mice, the results indicated that the combined treatment with high-dose 2'-FL and Lactobacillus plantarum 1.0642 significantly reduced serum levels of TNF-α, IL-1β, and IL-6 compared to other groups (P < 0.05), increased 5-HT, NE, BDNF, 5-HIAA, and DA levels, and reduced GABA levels (P < 0.05). Analysis via 16S rDNA gene sequencing, this combined treatment promoted the abundance of SCFAs producing bacteria, including Bacteroides, Bifidobacterium, Murella and Roseburia. Western blot analysis demonstrated that 2'-FL and L...."

IO biomarker • CNS Disorders • Constipation • Depression • Gastroenterology • Gastrointestinal Disorder • Inflammation • Inflammatory Bowel Disease • Mood Disorders • Psychiatry • BCL2 • IL1B • IL6 • TNFA

Current Treatment Options for Children with Functional Constipation-What Is in the Pipeline? (PubMed, Children (Basel)) - "New agents such as lubiprostone, prucalopride, linaclotide, and plecanatide have demonstrated improved outcomes compared to placebo or conventional therapies, particularly in increasing spontaneous bowel movements. Therapy-resistant FC in children is a complex and impactful condition. An individualized, stepwise approach is essential, with surgical options such as colonic resection reserved as a last resort."

Journal • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Pediatrics

Seoul Consensus on Clinical Practice Guidelines for Functional Constipation (PubMed, Korean J Gastroenterol) - "The benefits and cautions of new pharmacological agents (such as lubiprostone and linaclotide) and conventional laxatives have been described through a meta-analysis. The guidelines consist of 34 recommendations, including 3 concerning the definition and epidemiology of functional constipation, 9 regarding diagnoses, and 22 regarding management. Clinicians (including primary physicians, general health professionals, medical students, residents, and other healthcare professionals) and patients can refer to these guidelines to make informed decisions regarding managing functional constipation."

Clinical guideline • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder